You're listening to the Drugwatch podcast with your host Michelle Llamas. The Drugwatch podcast provides useful medical information directly from the experts to you. It also features the stories of consumers just like you who are affected by dangerous drugs and medical devices.
Drugwatch podcast is not a substitute for professional, legal, or medical advice. The views and opinions expressed by the host and guests do not necessarily reflect those of Drugwatch.

Michelle Llamas

Hi there, and welcome to another episode of the Drugwatch podcast. I'm your host Michelle Llamas, and on this episode today I've got Angie Firmalino, and she is the Founder of Essure Problems. After she suffered complications from Essure permanent birth control, she started the Facebook group called Essure Problems, and it has since spread all over social media.

Now the group has evolved also into a non-profit called ASHES, that fights for medical device safety. Welcome to the show, Angie.

Angie Firmalino

Thank you. Thank you for having me.

Michelle Llamas

First of all, just wanted to say that you and your fellow Essure Problems' ladies, E-sisters – right, as you call yourselves —

Angie Firmalino

Yep. Mm-hmm (affirmative).

Michelle Llamas

Have been doing such a great job getting this awareness out about Essure. Tell us about your medical journey that led to the founding of Essure Problems.

Angie Firmalino

Okay. After my son was born in 2009, I was implanted with Essure. I had problems right away. I had problems during the procedure itself, and then for the following two years, I suffered quite a few different complications.
I went in for a follow-up in 2011 where they ordered an ultrasound and found out that my devices had expelled. One was completely embedded in my uterus, and the other one was about 90 percent expelled into my uterus. I had to have surgery to remove them.
At that point, I started a group on Facebook and then named it Essure Problems. I wanted to add my girlfriends and my female family members so that I could warn them about what happened to me and just tell them about this device and tell them to stay away from it because I had no idea that it could expel and embed in my uterus. I just wanted to raise awareness for my friends.

Michelle Llamas

You found out, of course, all these things through your own personal experience, so you were like, "Oh my goodness." You wanted to make sure that everyone knew. If Facebook was a good way to do it, then start doing that, right? Then, you said it started growing, right? Friends and family turned into how many women, and then how many women after that?

Angie Firmalino

Yeah, so I just had added a handful of people that I knew to tell them about it, and we just started talking on this page, and then all of a sudden strangers that I didn't know started joining the group and telling their stories — similar stories, some pretty horrific stories — and it just started snowballing.
I remember when we got up to 65 people I thought that was huge. I thought, "Oh my god, there's 65 other women out there."

Michelle Llamas

Yeah, you're like big time now here: 65.

Angie Firmalino

Yeah. I thought that was huge, and I went back and told my doctor, "I have 65 women now in my group." I thought that was just a huge number, but yeah — it kept growing.

Michelle Llamas

Yeah. Let's say what about the final number is now too since you founded the group?

Angie Firmalino

We're up to over 36,000 in the main page. We've also sub-grouped out to about 50 other groups: groups in other countries, specialty groups like autoimmune disease after Essure, cancer after Essure, a military group. We've just ... We've grown so big that we've had to sub-group out.

Michelle Llamas

Wow. I'd like to point out, of course, all the women that are involved in this. They volunteer their time, right, to help run this?

Angie Firmalino

Absolutely.

Michelle Llamas

It's something that everyone that's involved in is personally attached to because they've had their own experiences, right?

Angie Firmalino

Exactly, yeah.

Michelle Llamas

The number of people involved in the group now is bigger than some small towns.

Angie Firmalino

Yeah.

Michelle Llamas

That's kind of ... when you think about it that way it's like, “Wow.” It's a movement now I would definitely say.

Angie Firmalino

Yeah.

Michelle Llamas

In the beginning you were just like, "Hey, I'm gonna warn my friends and family." You didn't actually set out to become this big group that was now going to D.C. and meeting with the commissioner of the FDA and being involved in law-making.

Angie Firmalino

Yeah. When these women started joining it kind of turned into a support group, and then it kind of evolved into an educational group where we would start sharing information to help each other like talk to their doctor or, "Oh, well I found this information on proper removal," or "Oh, I found this information on why this might be affecting our autoimmune system."
It was this kind of support in that way, and then it kind of turned into this advocacy movement because we found the 2002 pre-market approval transcript where they approved this device, where the FDA approved the device. After we read through that we were so angry with what we found there. Then it turned into a fight.

Michelle Llamas

Let's talk about a couple of things that you found that really ticked you guys off. I know that the clinical trials were shoddy.

Angie Firmalino

Yes.

Michelle Llamas

We know that they were run very poorly, but what else did you find?

Angie Firmalino

It was a very small number of women followed for a very short period of time. The panel that was there to ask this company Conceptus questions — they had all these different questions that the panel really didn't have answers for because they hadn't studied this long enough.
I went through, and I was just keeping track of all these questions and how this company didn't really have any answers. At one point, one of the panel members had asked, "What if in five years after we approve this device the pregnancy rates are higher? What are we gonna do then?" Another panel member joked and said, "In 10 years, they'll hire private investigators and bring us all back here and ask us why we approved this." Then they all laughed.
I was shaking I was so mad, and then I got to the end, and it said that this meeting has been video recorded by such-and-such company, and it had this phone number. I was like, "I'm gonna call them and see if they have a copy of this," and they did. Yeah. It was like $900 to get a copy of it.
I posted in the group. I'm like, "Ladies, I think we need this because I want to watch this meeting. I want to see if it matches the transcript. I want to see if there's anything else." Within like an hour everyone donated, we raised $900 bucks. I called the company back, and I ordered it, and I got those four DVDs.

Michelle Llamas

Oh boy, and did it live up to your expectations?

Angie Firmalino

Oh, that and then some, yeah.

Michelle Llamas

Oh gosh.

Angie Firmalino

Then, I called them back and I'm like, "I need to share this. Can I put this online? Can I put this on YouTube? Do I have permission?" They're like, "No. You'd have to buy the rights to it." I was like, "Oh my god, how much is that?" It was another several hundred dollars. I went back to the group and I’m like, “Girls…” They were like, “We’re on it.” And we raised the money.
I sent it to the guy, and he sent me his permission to use up to an hour or whatever it was, and so I made four 20 minute videos or 15 minute videos of just different clips from the four DVDs showing all of this information that was just lacking, and how they joked about it, and how the company just didn't have enough evidence to really approve this device, yet they did it anyways, so I put that out there.
Then it just started snowballing as far as media and getting attention from Erin Brockovich and her wanting to help us as well.

Michelle Llamas

This thing is a true ... It's the story of a true grassroots movement because that's how you guys started. Your story right there — it’s everybody just pulling together and getting this done. That's amazing. I think that is testament to the power of what a group of people can do when they get together. This was the beginning. You had no idea what else you were gonna do after all this.
Tell us about some of the difficulties that you faced and when you were beginning to try and take this from an advocacy group and go further.

Angie Firmalino

Wow, where do I begin?

Michelle Llamas

We don't want people to think this is easy. You know?

Angie Firmalino

Getting doctors to believe you. I think that is the thread that kind of ties all of us – all of the E-sisters — together is —

Michelle Llamas

Condescension.

Angie Firmalino

Doctors are very condescending, and they don't really want to listen to your problems or think that anything is wrong. Or how could that be related to this tiny little device, and this and that. Just to hear these women over and over again coming back to the page saying, "My doctor doesn't want to help me," or "My doctors doesn't believe me," or "My doctor put me on antidepressants," or "They gave me a script to go see a psychiatrist." It was just mind-blowing how these doctors were just dismissing everybody — just dismissing all of our problems.
It was just fuel to the fire to make us fight more, and so we started reaching out to doctors on Twitter, and we started sending letters to different organizations, and we reached out to ACOG, and we reached out to the AAGL, and we just really, really pounded on as many doors as we possibly could, and finally one or two doctors started joining the group. They started listening and helping and then started removing these devices, and then that started to snowball, and then we had this resource of doctors so we could finally start sending women to.
Like, "Okay, this one in this state will help you, and this one in this state will help you." It was just a constant fight. It felt like a constant fight. Two steps, three steps back. Like, we'd make a little progress here, and then we'd get pulled back, but we just kept trudging. There was no stopping us.

Michelle Llamas

We talked about some of the difficulties. What are the recent really amazing victories that this has led to?

Angie Firmalino

Finally, after pounding on the FDA’s door forever, we had one phone conference with them. I think it was in 2014 maybe and just continually sending them more and more information and more and more data. They finally called a public hearing in 2015 on the safety and efficacy of Essure. They had a new panel. They brought in Bayer, who now owns Essure. They bought it from Conceptus. The panel deliberated and asked all sorts of questions. They had public speaking allowed, so we all got up, and we shared our stories, and I shared information from the group, and there was hundreds of us there, and it was all day long.
I think it was a 12-hour event, and it's finally resulted in a black box warning being placed on the labeling, and a patient decision checklist that you're supposed to go over with your physician that included all of these new warnings that weren't previously included on the labeling. That was a small victory.
We started lobbying in congress. We've gotten a couple of bills introduced in the House. We've gotten a couple of co-sponsors for different bills we're trying to pass, so that's another battle we've been trying to fight, because —

Michelle Llamas

Yeah, that's not easy, right? Because you've got to head up to Washington every time —

Angie Firmalino

Yeah.

Michelle Llamas

You've got to head up to D.C.

Angie Firmalino

We found out through Erin Brockovich what being in Class III means for a medical device, and a Class III medical device like Essure, once they go through pre-market approval they get this thing called preemption protection. At the federal level, if you're injured or harmed or killed by a Class III medical device, you have no recourse in court. You can't file a lawsuit or it's next to impossible to file a lawsuit.
We're trying to change that law. In the meantime ... Over the years that we've been fighting we've been trying to find a law firm to battle this preemption. Finally, after years of collecting information and data and presenting it over and over again, one law firm finally said, "You know what? What you've brought me is worth looking into." He took it upon himself and filed the first couple of cases, and they got through. Now it's just... the litigation is just all over the place.

Michelle Llamas

The amazing thing, of course, is that so many of these cases are still alive now that the judges have not just tossed them out, right?

Angie Firmalino

Right, right.

Michelle Llamas

For preemption. The fight's still ongoing-

Angie Firmalino

The fight's still ongoing, yep.

Michelle Llamas

But, the fact that the cases have been allowed to continue is great in itself.

Angie Firmalino

Yes.

Michelle Llamas

Now, you're an example of someone that took something horrible that happened to them and turned it into this amazing vehicle for change. There are a lot of people that are affected by drugs, devices, all kinds of stuff.
What advice can you give to people who are looking for options to fight back against pharmaceutical companies and spread awareness?

Angie Firmalino

Social media. Just start pounding social media looking for groups, looking for anyone out there that shares a similar story. Try to find people that are willing to jump in with you and create something, create some sort of movement and fight to make change, connect with other groups.
One of the great things with Essure Problems is now we're connected to all these other medical device groups. We're connected with the breast implant groups and the mesh women and hip implants and DaVinci sufferers. There are so many groups out there so just search for them, find them. There are other victims out there that can support you, give you information on how to get help, give you information on how to help fight the cause. It's out there. You just have to ... you have to find your people.

Michelle Llamas

There is power in numbers, strength in numbers, right?

Angie Firmalino

Absolutely.

Michelle Llamas

That's what you're saying, just ban together.

Angie Firmalino

Yeah, and share information. Some other group might have information that our group doesn't have, and you just have to work with these other advocates.

Michelle Llamas

I guess like what you've been doing. You've got to be willing to talk to all the media that calls you, right?

Angie Firmalino

Yeah. Media's been our best friend. That's like number one to get attention on something, get as much media as you possibly can on it. Tell your story, get your story out there first, and then research your device, research how it was approved, research who approved it, and who was involved in the patents. Go as far back as you can. Follow the money trail. You'd be surprised at what you find. You know?

Michelle Llamas

Talked about some of the victories that you have. You've accomplished quite a bit as a group and as an individual. What's the next hurdle? The next battle for you guys?

Angie Firmalino

We just met with the commissioner of the FDA, Scott Gottlieb. We met with him in early February, and we asked him to suspend the device while waiting these new clinical trials that they ordered Bayer to do, so we're actually —

Michelle Llamas

Which aren't gonna come out until like 2023, right?

Angie Firmalino

2023.

Michelle Llamas

Yeah.

Angie Firmalino

Correct.

Michelle Llamas

Mm-hmm (affirmative).

Angie Firmalino

Yeah, and in the meantime, the device has been taken off the market in every other country. This is the only country where it remains. There has been several studies that have been coming out showing that Essure is less effective as a tubal ligation. Essure has a 10 times higher re-operation rate than tubal ligation.
There's finally some studies coming out showing that this isn't as safe and effective as the clinical studies have shown it to be. While we're waiting for Bayer to finish their new clinical study, and while we're waiting for a study that we helped launch, which is going to be a retrospective study looking at current people that have been implanted with Essure versus current people that have had tubal ligation —
Until these studies are complete, and we can get some actual large data, some long-term data, suspend it. Take it off the market, and then if it seems that it's safe and effective and you want to put it back on the market, then make it a mandate that they have to know about the black box warning and do the patient checklist. Because they made it a guidance and we're surveying the new women that come into our group that are recently implanted, and when we ask them, "Did your doctor tell you about the black box warning? Did they require you to do the checklist?" 95 percent of the women are saying, “No.”
The FDA making it a guidance was a complete failure. They needed to make it a mandate. So take it off the market, and then if you put it back on, please mandate those things because women are not getting informed consent without it.

Michelle Llamas

That's important because that was actually one of the reasons why they did that. They were like, "Hey, you need to warn women." They thought just sort of telling doctors to do that would be okay, but clearly people are still ... Plus, the black box warning is on the package, right?

Angie Firmalino

It's on the package.

Michelle Llamas

Women don't see the package.

Angie Firmalino

Nope, the patient doesn't even see it.

Michelle Llamas

Mm-hmm (affirmative).

Angie Firmalino

The patient never sees it. We sat down with the FDA while they had the draft guidance. They had an FDA docket with the draft wording of the guidance, and the black box warning, and people could make comments, and people could make suggestions, and everyone did. They got thousands and thousands of suggestions and comments, and then we had a sit-down meeting with them, and we asked them, "Why are you doing a guidance? Why are you not mandating this?"
Benjamin Fisher, who works at the FDA, said that, "A mandate takes two years, and that they thought it was more important to get something out quickly than to wait the two years to do the mandate." Well, it ended up taking them 18 months to get the guidance out. It's not being implemented.

You see sometimes, too, when there's maybe just a handful of people affected by something that they move on it much quicker, which is kind of funny, but then you have thousands of people here, thousands of women, and still.

Angie Firmalino

They don't know how to manage their own data. The MAUDE database is so inaccessible, and it's so hard for even a physician to use it. If a physician wants to go in and see, "Hey, how many people have been killed by this device?" they can't easily access that information in the MAUDE database, and that's where Madris Tomes comes in with her software Device Events-

Michelle Llamas

That's right.

Angie Firmalino

She can pull all this data in and do a keyword search, and we're having to bring this back to the FDA. When we sat down with the commissioner, Scott Gottlieb, in February, Madris came with us and she showed them like, "Okay, now we're up to this many deaths. Now we're up to this many fetal deaths. This is how many hysterectomies have been performed. This is how many," blah, blah, blah.
He just looked at her and he was like, "Where are you getting this information?" She said, "From your database." She was like, "It's your information that you guys can't even decipher." It's just mind-blowing.

Michelle Llamas

It is a mess that an outside person has to look at their data for them.

Angie Firmalino

Yeah.

Michelle Llamas

Yeah.

Angie Firmalino

There's so many other devices out there that need the same type of attention. Especially, this preemption protection that the Class III devices have. We think that this is a huge problem and we really want to correct that because ... just because your device is a Class III doesn't mean that you shouldn't have the same legal rights as someone who has a Class II device.

Michelle Llamas

Exactly.

Angie Firmalino

It doesn't make any sense. If you're injured or harmed, and you can prove that it was a defective device or a manufacturer issue, you should have the same rights.

Michelle Llamas

That's right. You should have recourse somewhere because you can't just say, "Well, sorry about your luck. You've been killed or maimed by this thing, but."

Angie Firmalino

Right. If you're gonna be disabled by something you should have some sort of protection, and —

Michelle Llamas

Especially, when it's negligence-related, right?

Angie Firmalino

Absolutely.

Michelle Llamas

It's defective.

Angie Firmalino

Absolutely.

Michelle Llamas

It's not user-error, shall we say?

Angie Firmalino

Right. And that's where the legal system comes in. If you have a case where you can prove that there was some sort of fraud or there was some sort of defect, then let the courts let it play out. Let the courts decide because that's where we have our checks and balances. If the manufacturer has no initiative to take something off of the market because they can't be held liable, they're just gonna leave it there, you know?

Michelle Llamas

That's true.

Angie Firmalino

That's basically what's going on right now.

Michelle Llamas

They keep making money off of it.

Angie Firmalino

Yeah, so if we're fortunate enough, which we have been, for a judge to actually open their eyes and look at this and listen to us and take a look at all this evidence, I really feel like it's going to turn in our favor.

Michelle Llamas

Well, thank you so much for coming on the show and sharing all your knowledge and your insights, Angie.

Angie Firmalino

Thank you.

Michelle Llamas

Best of luck, though I'm sure it has nothing to do with luck because you have worked very hard —

Angie Firmalino

Thank you.

Michelle Llamas

To get to where you guys are, so hopefully everything ends up being safer in the end some way or another.

Angie Firmalino

Yep. I hope so, thank you.

Michelle Llamas

Thank you for listening to this episode of the Drugwatch podcast. For more information on this episode, or if you would like to be a guest on the show, visit drugwatch.com or email Michelle Llamas. Drugwatch podcast is not a substitute for professional, legal or medical advice.
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Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

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